Title: AQA reviewer
Date: 28 Oct 2024
Job Location: Bangalore
Pay Grade: 8-I
Year of Experience: 9 - 12 Years
Job Description
Designation: Junior Manager
Job Location: Bangalore
Department: Analytical Quality Assurance
About Syngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation
.
Key Responsibilities
- Review of analytical raw data (through ELN / manual) generated by analyst, protocols/ reports pertaining to the section as per the standard operating procedure and specification.
- Ensuring, verifying, and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.
- Review of Outsourced analytical report.
- Review of logbooks with respect to all activity performed in the lab.
- Responsible for taking any other job allocated by Department Head / Department In charge.
- Review of technical data in analytical document viz. Calculations, Chromatograms, method parameters, integration, logbook entries, WS/RS and Column usage records, method parameters, reconciliation, vendor COA and other technical data in analytical document.
- Responsible to ensure review and release of raw material and packing material in LIMS/SAP.
- Responsible to ensure review and release of cleaning samples, inprocess samples, calibration reports and standard qualification reports.
- Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents.
- Review the documents for completeness, compliance to good documentation practices, test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable
- Review of all the tests as specified in the specification/Request for analysis /validation protocol/sampling protocol have been carried out
- Review of all supporting documents like chromatograms, balance print outs, Instrument printouts are enclosed in sequential manner to the parent report with signature as applicable
- Review of the test results in COA against specification along with other relevant sample information before approval.
- In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory.
- Ensuring of conducting regular GMP rounds at Quality Control Laboratory.
- Involving in the Laboratory incident investigation, review, and approval.
Educational Qualification: M. Sc (Life science / Chemistry)/ M. Pharm
Technical/functional Skills
- Good exposure in Enterprise Applications like SAP, Learning Management Systems, Trackwise, and Analytical laboratory Applications like Chromatography and Non-chromatography data Management.
- Well versed in electronic data audit review.
- Good Knowledge on handling the application software.
- Establish good Interpersonal skills with cross-functional teams.
Experience: 9 to 12 Years experience in life science industry.
Behavioural Skills
- Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
- Good speaking-listening-writing skills, attention to details, proactive self-starter.
- Ability to work successfully in a dynamic, ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Ability to develop new ideas and creative solutions.
- Should be able to work in team and flexible for working in shifts.
- Should be a focused employee.
Equal Opportunity Employer
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
